| AMS ACTICON NEOSPHINCTER-ARTIFICIAL BOWL SPHINCTER (ABS) (P010020/S027) | Boston Scientific Corp | 2013-02-06 |
| HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S038) | CooperSurgical, Inc. | 2013-02-06 |
| ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P980041/S021) | Beckman Coulter, Inc. | 2013-02-06 |
| ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P970038/S020) | Beckman Coulter, Inc. | 2013-02-06 |
| AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S094) | Boston Scientific Corp | 2013-02-06 |
| ACCESS HYBRITECH P2PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (P090026/S004) | Beckman Coulter, Inc. | 2013-02-06 |
| NUVASIVE'S PCM CERVICAL DISC (P100012/S001) | Nuvasive, Inc. | 2013-02-06 |
| VITUOSO DR, VIRTUOSO VR, VIRTUOSO II DR, VIRTUOSO II VR, SECURA DR, SECURA VR, PROTECTA XT DR, PROTECTA XT VR (P980016/S389) | Medtronic Cardiac Rhythm Disease Management | 2013-02-05 |
| CERVISTA HPV HR COMPONENTS (P080014/S011) | Hologic, Inc. | 2013-02-04 |
| CERVISTA HPV 16/18 COMPONENTS (P080015/S006) | Hologic, Inc. | 2013-02-04 |
| VNS THERAPY SYSTEM (P970003/S154) | LivaNova USA, Inc. | 2013-02-01 |
| NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S041) | Hologic, Inc. | 2013-02-01 |
| XIENCE AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S093) | Abbott Vascular, Inc. | 2013-02-01 |
| PHILOS DR-T,PHILOS II DR-T, CYLOS DR-T, EVIA DR-T,EVIA SR-T, ENTOVIS DR-T,ENTOVIS SR-T (P950037/S117) | Biotronik, Inc. | 2013-01-31 |
| BELOS VR-T (P980023/S050) | Biotronik, Inc. | 2013-01-31 |
| BELOS VR-T, BELOS DR-T, BELOS A +-T, LEXOS DR-T,LEXOS VR-T,XELOS DR-T, LUMOS DR-T,LUMOS VR-T (P000009/S052) | Biotronik, Inc. | 2013-01-31 |
| STRATOS LV-T (P070008/S037) | Biotronik, Inc. | 2013-01-31 |
| LUMAX 300 DR-T,LUMAX 340 DR-T, LUMAX 300 VR-T, LUMAX 340 VR-T, LUMAX 500 DR-T, LUMAX 540 DR-T, LUMAX 500 VR-T, LUMAX 540 (P050023/S059) | Biotronik, Inc. | 2013-01-31 |
| VASCADE VASCULAR CLOSURE SYSTEM (P120016) | Cardiva Medical, Inc. | 2013-01-31 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S006) | Edwards Lifesciences, LLC | 2013-01-30 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S044) | Boston Scientific Corp | 2013-01-30 |
| CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESES WITH THERMAFIX TISSUE PROCESS (P860057/S102) | Edwards Lifesciences, LLC | 2013-01-30 |
| EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S020) | Edwards Lifesciences, LLC | 2013-01-30 |
| TITAN INFLATABLE PENILE PROSTHESIS (P000006/S029) | Coloplast Corp. | 2013-01-29 |
| PARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL UNSULIN PUMP (P980022/S125) | Medtronic Minimed | 2013-01-29 |
| VIVA XT CRT-D, VIVA S CRT-D, BRAVA CRT-D, VIVA/BRAVA/EVERA SOFTWARE APPLICATION (P010031/S318) | Medtronic Cardiac Rhythm Disease Management | 2013-01-29 |
| PHACO-FLEX AND TECHIS CL SILICONE ULTRAVIOLENT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P880081/S038) | Johnson & Johnson Surgical Vision, Inc. | 2013-01-29 |
| OCUCOAT HPMC VISCOELASTIC (P860047/S027) | Bausch & Lomb, Inc. | 2013-01-29 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S018) | Boston Scientific Corp | 2013-01-29 |
| ION PACLITAXEL-ELUTING CHROMIUM CORONARY STENT SYSTEM (P100023/S047) | Boston Scientific Corp | 2013-01-29 |
| MEDTRONIC CARELINK MONITOR, CARDIOSIGHT READER, CARELINK EXPRESS (P890003/S253) | Medtronic, Inc. | 2013-01-29 |
| SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) (P090022/S012) | Lenstec, Inc. | 2013-01-29 |
| LATITUDE WAVE COMMUNICATOR (MODEL 6498) (P910077/S119) | Boston Scientific | 2013-01-28 |
| LINX REFLUX MANAGEMENT SYSTEM (P100049/S003) | Torax Medical | 2013-01-24 |
| ACCULINK CAROTID STENT SYSTEM (P040012/S051) | Abbott Vascular | 2013-01-24 |
| ORAQUICK HCV RAPID ANTIBODY TEST (P080027/S008) | OraSure Technologies, Inc. | 2013-01-24 |
| XACT CAROTID STENT SYSTEM (P040038/S028) | Abbott Vascular, Inc. | 2013-01-24 |
| MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (P040044/S046) | Cordis US Corporation | 2013-01-24 |
| SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE) (P050050/S005) | Djo Global | 2013-01-24 |
| ROTABLATOR ROTATIONAL ARTHERECTOMY SYSTEM (P900056/S119) | Boston Scientific Corp | 2013-01-24 |
| RX HERCULINK ELITE RENAL STENT SYSTEM (P110001/S010) | Abbott Vascular | 2013-01-24 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S006) | Abbott Vascular, Inc. | 2013-01-24 |
| BLAZER PRIME XP AND BLAZER II XP CARDIAC ABLATION CATHETERS (P020025/S037) | Boston Scientific | 2013-01-22 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S010) | Infusyn Therapeutics, LLC | 2013-01-22 |
| COGNIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, INCEPTA CARDIAC RESYNCHRONICATION THERAPY-DEBIBRILLATOR,ENERGEN (P010012/S318) | Boston Scientific Corp | 2013-01-22 |
| TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ENERGEN IMPLANTABLE CARD (P960040/S284) | Boston Scientific | 2013-01-22 |
| IMPLANTABLE MINIATURE TELESCOPE (P050034/S008) | Samsara Vision, Inc. | 2013-01-22 |
| BLAZER II AND BLAZER PRIME HTD CARDIAC ABLATION CATHETERS (P920047/S054) | Boston Scientific Corp | 2013-01-22 |
| COGNIS CRT-D, LIVIAN CRT-D, CONTAK RENEWAL 3 RF HE CRT-D (P010012/S301) | Boston Scientific Corp | 2013-01-18 |
| VIDAS TOTAL PSA (P040008/S003) | bioMerieux, Inc. | 2013-01-18 |
| PIPELINE EMBOLIZATION DEVICE (P100018/S005) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2013-01-18 |
| VIDAS FREE PSA RT (P080008/S002) | bioMerieux, Inc. | 2013-01-18 |
| TECHNOLAS 217A EXCIMER LASER SYSTEM AND TECHNOLAS 217Z ZYOPTIX SYSTEM (P990027/S017) | Technolas Perfect Vision GmbH | 2013-01-18 |
| ACRYSOF INTRAOCULAR LENSES (P930014/S065) | Alcon Laboratories, Inc. | 2013-01-17 |
| METHAFILCON A AND METHAFILCON B SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P850079/S064) | CooperVision, Inc. | 2013-01-17 |
| PROPEL MINI SINUS IMPLANT (P100044/S005) | Intersect Ent. | 2013-01-17 |
| SPRINT QUATTRO SECURE LEAD (P920015/S104) | Medtronic, Inc. | 2013-01-17 |
| BIOFINITY (COMFILCON A) SOFT CONTACT LENSES (P080011/S022) | CooperVision, Inc. | 2013-01-17 |
| BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P080011/S021) | CooperVision, Inc. | 2013-01-17 |
| VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S035) | Vistakon, Division of Johnson & Johnson Vision Car | 2013-01-17 |
| ACRYSOF RESTOR POSTERIOR CHAMBER INTRAOCULAR LENSES (P040020/S044) | Alcon Research, Ltd. | 2013-01-17 |
| PARADYM CRT-D, PARADYM RF CRT-D (P060027/S046) | MicroPort CRM USA, Inc. | 2013-01-16 |
| SCULPTRA, SCULPTRA AESTHETIC (P030050/S013) | Q-Med AB | 2013-01-16 |
| MEDSTREAM PROGRAMMABLE INFUSION SYSTEM CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP (P890055/S047) | Intera Oncology | 2013-01-16 |
| PRECISION SOINAL CORD STIMULATOR SYSTEM (P030017/S151) | Boston Scientific Corp | 2013-01-16 |
| EON MINI LE CHARGER, EON MINI LE CHARGING SYSTEM (P010032/S065) | ABBOTT MEDICAL | 2013-01-16 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S027) | Bard Peripheral Vascular | 2013-01-16 |
| PARADYM VR AND DR, PARADYM RF VR AND DR (P980049/S078) | MicroPort CRM USA, Inc. | 2013-01-16 |
| ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR (P980035/S277) | Medtronic, Inc. | 2013-01-15 |
| VITATRON CRYSTALLINE LEAD (P930039/S081) | Medtronic, Inc. | 2013-01-15 |
| VIDAS TOTAL PSA (P040008/S004) | bioMerieux, Inc. | 2013-01-15 |
| INVIVE CARDIAC RESYNCHRONIZATION THERAPY - PACEMAKER (CRT-P) (P030005/S096) | Guidant Corp. | 2013-01-15 |
| INTEGRITY RX CORONARY STENT SYSTEM, INTEGRITY OTW CORONARY STENT SYSTEM (P030009/S062) | Medtronic, Ireland | 2013-01-15 |
| CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER (P890003/S252) | Medtronic, Inc. | 2013-01-15 |
| SPRINT QUATTRO LEAD (P920015/S103) | Medtronic, Inc. | 2013-01-15 |
| GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (P040037/S045) | W. L. Gore & Associates, Inc. | 2013-01-15 |
| HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICE (OVD) (3 (P810031/S046) | Johnson & Johnson Surgical Vision, Inc. | 2013-01-11 |
| BRYAN CERVICAL DISC (P060023/S004) | Companion Spine France Sas | 2013-01-11 |
| COROX OTW 75-UP STEROID LEAD, COROS OTW 85-UP STEROID LEAD (P050023/S056) | Biotronik, Inc. | 2013-01-11 |
| GENESYS HTA SYSTEM (P000040/S026) | Axora Medical, Inc. | 2013-01-11 |
| FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S036) | Medtronic, Inc. | 2013-01-10 |
| HANCOCK LOW POROSITY CONDUIT MODEL 105 (P870078/S015) | Medtronic, Inc. | 2013-01-10 |
| INCEPTA, ENERGEN, PUNCTUA, COGNIS CRT-D'S (P010012/S317) | Boston Scientific Corp | 2013-01-10 |
| ROCHE COBAS DNA SAMPLE PREPARATION KIT,059855536190 AND ROCHE COBAS 4800 BRAF V600 MUTATION KIT, 05985579190 (P110020/S006) | Roche Molecular Systems, Inc. | 2013-01-10 |
| INCEPTA, ENERGEN, PUNCTUA, TELIGEN ICD'S (P960040/S283) | Boston Scientific | 2013-01-10 |
| HANCOCK II PORCINE BIOPROSTHESIS (P980043/S034) | Medtronic, Inc. | 2013-01-10 |
| MOSIAC PORCINE BIOPROSTHESIS (P990064/S041) | Medtronic, Inc. | 2013-01-10 |
| ANGIOSCULPT PTCA SCORING BALLOON CATHETER (P050018/S017) | Spectranetics Corp. | 2013-01-10 |
| HANCOCK MODIFIED ORIFICE VALVED CONDUIT MODEL 150 (P790007/S032) | Medtronic Heart Valves | 2013-01-10 |
| INVIVE CRT-P (P030005/S094) | Guidant Corp. | 2013-01-10 |
| ARISTA AH ABSORBABLE HEMOSTAT (P050038/S013) | Davol, Inc. | 2013-01-10 |
| ARCHITECT I1000 SYSTEM (P110029/S001) | Abbott Laboratories | 2013-01-10 |
| MYNX CADENCE AND MYNXGRIP VASCULAR CLOSURE DEVICES (P040044/S044) | Cordis US Corporation | 2013-01-09 |
| SURGIFOAM ABSORBABLE GELATIN SPONGE (P990004/S023) | Ferrosan Meidcal Devices A/S | 2013-01-09 |
| COOPERVISION COMFILCON A SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P080011/S020) | CooperVision, Inc. | 2013-01-09 |
| EON NEUROSTIMULATION SYSTEM (P010032/S059) | ABBOTT MEDICAL | 2013-01-09 |
| ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S039) | Boston Scientific Corp | 2013-01-09 |
| ARISTA AH ABSORBABLE HEMOSTAT (P050038/S012) | Davol, Inc. | 2013-01-09 |
| APTIMA HCV RNA QUALITATIVE ASSAY (P020011/S006) | Gen-Probe | 2013-01-09 |
| SCS ACCESSORIES,SCS 1X8 EXTENSION,SCS QUADRIPOLAR EXTENSION,SCS LEADS SPECIFY FAMILY,SCS LEADS 1X8 FAMILY,SCS LEADS (P840001/S231) | Medtronic Neuromodulation | 2013-01-08 |